← FDA DRUG APPROVALS

FDA NDA · NDA206439

NAMZARIC

memantine hydrochloride and donepezil hydrochloride

Sponsor: ABBVIE

APPLICATION
NDA206439
TYPE
NDA
ORIGINAL APPROVAL
2014-12-23
LATEST ACTION
2016-07-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

NAMZARIC · ReferencePrescription
DONEPEZIL HYDROCHLORIDE 10MG, MEMANTINE HYDROCHLORIDE 28MG · CAPSULE, EXTENDED RELEASE · ORAL
NAMZARIC · ReferencePrescription
DONEPEZIL HYDROCHLORIDE 10MG, MEMANTINE HYDROCHLORIDE 7MG · CAPSULE, EXTENDED RELEASE · ORAL
NAMZARIC · ReferencePrescription
DONEPEZIL HYDROCHLORIDE 10MG, MEMANTINE HYDROCHLORIDE 14MG · CAPSULE, EXTENDED RELEASE · ORAL
NAMZARIC · ReferencePrescription
DONEPEZIL HYDROCHLORIDE 10MG, MEMANTINE HYDROCHLORIDE 21MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2016-07-18Efficacy · Supplement 3 · standard — Letter ↗AP
2015-10-06Manufacturing (CMC) · Supplement 2 · standardAP
2015-09-01Manufacturing (CMC) · Supplement 1 · standardAP
2014-12-23Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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